WS/T 505-2017 Active Industry standards-Health

WS/T 505-2017 Guideline for evaluation of qualitative test performance

Publish Date: 2017-09-06 Implement Date: 2018-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: WS/T 505-2017

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Health

ICS Name: Laboratory medicine

Publish Date: 2017-09-06

Implement Date: 2018-03-01

Pages: 29 pages

Scope

This standard specifies the evaluation methods for qualitative determination performance. The qualitative determination described in this standard is limited to methods with only two detection results (for example, positive/negative, reactive/non-reactive). For methods reporting results as negative, +1, +2, +3, +4 or semi-quantitative titration, the precision and methodological comparative tests covered by this standard can only be used for their critical values.
This standard is applicable to laboratories conducting various types of qualitative detection, as well as manufacturers, regulatory authorities, and laboratory inspectors who need to study or describe the detection performance of qualitative diagnostic kits.